Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We are looking for a strategic and hands-on VP, Biometrics to lead biometrics across our full portfolio - from IND-enabling studies through registration, launch, and post-approval. Reporting into the Chief Medical Officer, you will build and lead our biostatistics, statistical programming & analysis, and clinical data management functions, balancing hands-on execution with oversight of internal team members and external vendors/contractors. This is a rare opportunity to build a world-class biometrics function from the ground up - if that excites you, we want to hear from you. How you might spend your days * Building and maintaining a high performing team across biostatistics, statistical programming & analysis, and clinical data management functions * Shaping clinical data strategy, study designs, statistical analysis, reporting, and regulatory interactions for Phase 1 through Phase 4 trials * Partnering with clinical development, regulatory affairs, pharmacovigilance, operations, and medical writing functions to drive data-driven business decisions and regulatory approvals * Overseeing external consultants, vendors, and contract research organizations (CROs) to support an expanding pipeline * Ensuring adherence to global regulatory standards, Good Clinical Practice (GCP), and CDISC guidelines * Serving as AbCellera’s subject matter expert on biometrics and biostatistical trends, advising internal stakeholders and the Board of Directors on quantitative methodologies and associated tools in drug development * Partnering on interactions with global regulatory agencies and the creation of high quality regulatory documents including study reports, clinical protocols, safety updates, NDA/BLAs, etc. We’d love to hear from you if * You have at least 15 years of leadership experience in the biotech or pharmaceutical industry, with at least 12 years focused on biostatistics, statistical programming and data management, ideally within both large and small organizations * You have extensive expertise with major regulatory submissions such as NDAs or BLAs, as well as experience representing biometrics in end of phase meetings, advisory committees, or similarly critical regulatory interactions * You have an advanced degree (Master’s or Ph.D.) in Biostatistics, Statistics, Mathematics, or a related quantitative discipline * You have an expert level understanding of ICH guidelines, GCP, and CDISC standards * You have a proven track record attracting, coaching, and leading top talent in biometrics teams * You thrive as a collaborative team member in a highly cross-functional environment, and lead with a curiosity-focused mindset What we offer In addition to a competitive base salary, we offer equity, an annual bonus dependent on individual and company performance, and a 6% (non-match) 401K contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. And you’ll find a strong sense of community and connections across AbCellera through our work. About AbCellera Creating medicines is the most important work we can do. We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications. We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience. We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. To apply Please submit your application through our website and refer to Job ID 23399 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.

VP, Biometrics

Similar jobs

Explore related jobs

Similar jobs